Docetaxel and Bortezomib in Treating Patients With Progressive or Recurrent Non-Small Cell Lung Cancer

Criteria:

• No other prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer for which the patient is currently in complete remission, or any other cancer for which the patient has been disease-free for 5 years.
• Histologically or cytologically confirmed non-small cell lung cancer (NSCLC).
• Progressive or recurrent NSCLC after treatment with 1 prior platinum-based chemotherapy regimen for metastatic disease. Prior neoadjuvant/adjuvant chemotherapy and/or concurrent chemoradiation for early-stage disease allowed.
• At least 4 weeks since prior chemotherapy (6 weeks for mitomycin C or nitrosoureas) and recovered.
• No prior docetaxel or bortezomib
• Prior epidermal growth factor receptor inhibitor therapy allowed.
• Prior paclitaxel allowed
• At least 4 weeks since prior major surgery and recovered.
• At least 2 weeks since prior and no concurrent enzyme-inducing anticonvulsants.
• No concurrent hormonal therapy, biologic therapy, or radiotherapy to measurable lesions. Concurrent palliative radiotherapy to small-field nonindicator lesions (e.g., painful bony metastases) allowed.
• Measurable disease* with >= 1 unidimensionally objectively measurable lesion, including any of the following:
• Lung mass (measurable on chest x-ray, tomograms, or CT scan)
• Enlarged lymph nodes
• Liver metastasis (measurable as a discrete focal lesion on radionuclide or CT scan, or ultrasound)
• Metastatic abdominal mass (measurable on CT scan with >= 1 perpendicular diameter ≥ the distance between cuts)
• Measurable disease must be outside the previous radiation field or a new lesion must be present.
• Life expectancy >= 12 weeks
• Progressive disease within a previously radiated field allowed.
• [Note: *Measurable disease DOES NOT include bone metastases or non-focal liver metastases].
• No symptomatic or untreated brain metastasis requiring steroids. Asymptomatic, previously treated (surgical resection or radiotherapy) brain metastasis allowed provided they are neurologically stable and >= 4 weeks since prior steroids.
• Creatinine clearance >= 50 mL/min
• Creatinine =< 1.6 mg/dL
• Bilirubin normal
• AST =< 2 times upper limit of normal
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No peripheral neuropathy >= grade 2
• Absolute granulocyte count >= 1,500/mm³
• Platelet count >= 100,000/mm³
• Cutaneous nodule
• ECOG performance status 0-1
• At least 4 weeks since prior radiotherapy and recovered.